Ensuring performance and meeting regulatory requirements in the pharmaceutical industry

Installation Qualification (IQ) and Operational Qualification (OQ) are 'validation and verification' quality assurance standards used throughout the pharmaceutical industry to ensure instruments used in laboratories fulfil and conform to legal requirements and guidance for cGMP as specified by U.S. FDA, Health Canada and other non-U.S. pharmaceutical quality management requirements.

IQ focuses on validation that an instrument and its components have been supplied as ordered and properly installed, that it delivers to the requirements for a specific application, and that the supplier delivers sufficient documentation to the client to enable future maintenance and performance. OQ confirms that the equipment is able to perform the task for which it is intended and demonstrates that the instrument will function according to its operational specifications.

Quantitative color determination methods using color measurement instrumentation offers multiple improvements over visual assessment methods, providing greater insight into lot-to-lot variability, precise color tracking of multiple lots, and can be used to verify color quality in liquid APIs, excipients and concentrated liquid proteins.

Failure to establish documented evidence that your color measurement instrument and your manufacturing process will consistently yield a quality product can have disastrous results to include high quality costs, risk of product recalls, loss of business and market share, and legal consequences that can be costly and potentially devastating.

Sign up now for this 45-minute webinar which will discuss IQ/OQ methods for color measurement instrumentation, intended to help biotech and pharmaceutical improve performance and meet regulatory requirements in the pharmaceutical industry.

HunterLab specializes in helping pharmaceutical companies realize greater performance by moving from qualitative visual color assessment to quantitative color determination. For more information, view our recent webinar presentation 'What Color is your Drug Solution? Qualitative vs. Quantitative Color Measurement - An eye toward setting pharmaceutical color specifications in the future'.